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NCT06646276PHASE3Recruiting

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

Bristol-Myers Squibb

Start Date

2/25/2025

Completion Date

9/5/2031

Summary

The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). * Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale. * Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system Exclusion Criteria * Participants have already received certain types of treatment for extensive stage small cell lung cancer * Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

BIOLOGICAL

BMS-986489 (BMS-986012+Nivolumab)

BIOLOGICAL

Atezolizumab

DRUG

Carboplatin

DRUG

Etoposide

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Conditions

Extensive-Stage Small Cell Lung Cancer

Locations

Southern Cancer Center, PC

Daphne, Alabama 36526

United States

Local Institution - 0283

Hot Springs, Arkansas 71913

United States

Florida Cancer Specialists - South

Fort Myers, Florida 33901

United States

Mid Florida Hematology and Oncology Center

Orange City, Florida 32763

United States

Florida Cancer Specialists - North

St. Petersburg, Florida 33705

United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia 30060

United States

Illinois Cancer Care

Peoria, Illinois 61615

United States

Local Institution - 0037

Minneapolis, Minnesota 55407

United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico 87106

United States

Duke Cancer Institute

Durham, North Carolina 27710

United States

Sanford Medical Center

Bismarck, North Dakota 58501

United States

Sanford Fargo Medical Center

Fargo, North Dakota 58102

United States

Oncology Hematology Care

Cincinnati, Ohio 45242

United States

Sanford Cancer Center

Sioux Falls, South Dakota 57104

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Texas Oncology - Central/South Texas

Austin, Texas 78705

United States

Texas Oncology - Northeast Texas

Tyler, Texas 75702

United States

Oncology & Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia 24014

United States

Swedish Cancer Institute - Edmonds

Edmonds, Washington 98026

United States

Swedish Medical Center

Seattle, Washington 98104

United States

Local Institution - 0079

Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ

Argentina

Local Institution - 0077

ABB, Buenos Aires F.D. C1199ABB

Argentina

Local Institution - 0100

Buenos Aires, Buenos Aires F.D. C1417DTB

Argentina

Local Institution - 0080

CABA, Buenos Aires F.D. C1430EGF

Argentina

Local Institution - 0094

Río Cuarto, Córdoba Province X5800AEV

Argentina

Local Institution - 0202

Campbelltown, New South Wales 2560

Australia

Local Institution - 0106

Penrith, New South Wales 2750

Australia

Local Institution - 0105

Brisbane, Queensland 4120

Australia

Local Institution - 0190

Ballarat Central, Victoria 3350

Australia

Local Institution - 0175

Murdoch, Western Australia 6150

Australia

Local Institution - 0253

Graz, Styria 8036

Austria

Local Institution - 0251

Wels, Upper Austria 4600

Austria

Local Institution - 0252

Linz, 4021

Austria

Local Institution - 0255

Rankweil, 6830

Austria

Local Institution - 0198

Brussels, Bruxelles-Capitale, Région de 1200

Belgium

Local Institution - 0091

Ghent, Oost-Vlaanderen 9000

Belgium

Local Institution - 0187

Sint-Niklaas, Oost-Vlaanderen B-9100

Belgium

Local Institution - 0092

Liège, 4000

Belgium

Local Institution - 0166

Fortaleza, Ceará 60135-237

Brazil

Local Institution - 0165

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Local Institution - 0169

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Local Institution - 0170

Santa Cruz do Sul, Rio Grande do Sul 96830-180

Brazil

Local Institution - 0163

Itajaí, Santa Catarina 88301-220

Brazil

Local Institution - 0178

Barretos, São Paulo 14784400

Brazil

Local Institution - 0111

São Paulo, São Paulo 01509-010

Brazil

Local Institution - 0289

Edmonton, Alberta T6G 1Z2

Canada

Local Institution - 0290

Chicoutimi, Quebec G7H 5H6

Canada

Local Institution - 0288

Québec, Quebec G1V 4G5

Canada

Local Institution - 0287

Rimouski, Quebec G5L 5T1

Canada

Local Institution - 0086

Santiago, Santiago Metropolitan 0

Chile

Local Institution - 0085

Santiago, Santiago Metropolitan 7500921

Chile

Local Institution - 0083

Santiago, Santiago Metropolitan 8330032

Chile

Local Institution - 0084

Santiago, Santiago Metropolitan 8420383

Chile

Local Institution - 0082

Viña del Mar, Valparaiso 2520598

Chile

Local Institution - 0204

Beijing, Beijing Municipality 100142

China

Local Institution - 0336

Beijing, Beijing Municipality 101149

China

Local Institution - 0203

Chongqing, Chongqing Municipality 400030

China

Local Institution - 0308

Fuzhou, Fujian 350014

China

Local Institution - 0212

Xiamen, Fujian 361003

China

Local Institution - 0234

Shantou, Guangdong 515000

China

Local Institution - 0227

Harbin, Heilongjiang 150081

China

Local Institution - 0209

Wuhan, Hubei 430079

China

Local Institution - 0208

Wuhan, Hubei 430100

China

Local Institution - 0216

Changsha, Hunan 410013

China

Local Institution - 0233

Nanchang, Jiangxi 330006

China

Local Institution - 0244

Changchun, Jilin 132000

China

Local Institution - 0235

Shenyang, Liaoning 110042

China

Local Institution - 0335

Xi'an, Shaanxi 710126

China

Local Institution - 0200

Jinan, Shandong 250117

China

Local Institution - 0206

Shanghai, Shanghai Municipality 200030

China

Local Institution - 0210

Shanghai, Shanghai Municipality 200032

China

Local Institution - 0186

Shanghai, Shanghai Municipality 200120

China

Local Institution - 0330

Chengdu, Sichuan 610041

China

Local Institution - 0213

Tianjin, Tianjin Municipality 300060

China

Local Institution - 0236

Hangzhou, Zhejiang 310016

China

Local Institution - 0237

Hangzhou, Zhejiang 310022

China

Local Institution - 0229

Linhai, Zhejiang 317000

China

Local Institution - 0114

Brno, Brno-město 656 53

Czechia

Local Institution - 0117

Ostrava, Ostrava Město 703 00

Czechia

Local Institution - 0113

Prague, Praha 4 14059

Czechia

Local Institution - 0116

Olomouc, 779 00

Czechia

Local Institution - 0048

Montpellier, Hérault 34090

France

Local Institution - 0040

La Tronche, Isère 38700

France

Local Institution - 0052

Lille, Nord 59037

France

Local Institution - 0044

Gleizé, Rhône 69400

France

Local Institution - 0051

Pierre-Bénite, Rhône 69310

France

Local Institution - 0047

Créteil, Val-de-Marne 94010

France

Local Institution - 0038

Villejuif, Val-de-Marne 94800

France

Local Institution - 0043

Marseille, 13915

France

Local Institution - 0050

Paris, 75248

France

Local Institution - 0215

Quimper, 29000

France

Local Institution - 0256

Frankfurt am Main, Hesse 60488

Germany

Local Institution - 0262

Oldenburg, Lower Saxony 26121

Germany

Local Institution - 0261

Cologne, North Rhine-Westphalia 51109

Germany

Local Institution - 0265

Halle, Saxony-Anhalt 06120

Germany

Local Institution - 0257

Bad Berka, Thuringia 99437

Germany

Local Institution - 0258

Gauting, 82131

Germany

Local Institution - 0259

Großhansdorf, 22927

Germany

Thoraxklinik-Heidelberg gGmbH

Heidelberg, 69126

Germany

Local Institution - 0264

Stuttgart, 70736

Germany

Local Institution - 0063

Athens, Attikí 115 26

Greece

Local Institution - 0064

Athens, Attikí 115 27

Greece

Local Institution - 0062

Thessaloniki, Kentrikí Makedonía 540 07

Greece

Local Institution - 0058

Thessaloniki, Thessaloníki 570 01

Greece

Local Institution - 0059

Larissa, Thessalía 41110

Greece

Local Institution - 0274

Bengaluru, Karnataka 560017

India

Local Institution - 0278

New Delhi, National Capital Territory of Delhi 110029

India

Local Institution - 0271

Madurai, Tamil Nadu 625107

India

Local Institution - 0277

Varanasi, Uttar Pradesh 221005

India

Local Institution - 0273

Kolkata, West Bengal 700094

India

Local Institution - 0072

Naples, Campania 80131

Italy

Local Institution - 0068

Milan, Lombardy 20133

Italy

Local Institution - 0069

Rome, Roma 00144

Italy

Local Institution - 0110

Perugia, Umbria 06132

Italy

Local Institution - 0070

Peschiera del Garda, Verona 37019

Italy

Local Institution - 0074

Bologna, 40138

Italy

Local Institution - 0067

Milan, 20141

Italy

Local Institution - 0319

Matsuyama, Ehime 791-0280

Japan

Local Institution - 0292

Kurume, Fukuoka 830-0011

Japan

Local Institution - 0313

Sapporo, Hokkaido 0608648

Japan

Local Institution - 0323

Kobe, Hyōgo 650-0047

Japan

Local Institution - 0321

Kanazawa, Ishikawa-ken 920-8641

Japan

Local Institution - 0316

Yokohama, Kanagawa 236-0051

Japan

Local Institution - 0291

Sendai, Miyagi 9810914

Japan

Local Institution - 0324

Kashihara, Nara 634-8522

Japan

Local Institution - 0328

Kurashiki, Okayama-ken 710-8602

Japan

Local Institution - 0317

Hirakata, Osaka 573-1191

Japan

Local Institution - 0314

Ōsaka-sayama, Osaka 589-8511

Japan

Local Institution - 0325

Takatsuki, Osaka 569-8686

Japan

Local Institution - 0320

Hidaka, Saitama 350-1298

Japan

Local Institution - 0318

Ina-machi, Saitama 362-0806

Japan

Local Institution - 0322

Hamamatsu, Shizuoka 431-3192

Japan

Local Institution - 0326

Bunkyo-ku, Tokyo 1138603

Japan

Local Institution - 0315

Koto, Tokyo 135-8550

Japan

Local Institution - 0327

Fukushima, 960-1295

Japan

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur 50586

Malaysia

Local Institution - 0312

Kuala Lumpur, Kuala Lumpur 50603

Malaysia

Local Institution - 0311

Kuching, Sarawak 93586

Malaysia

Local Institution - 0146

Guadalajara, Jalisco 44630

Mexico

Local Institution - 0145

Puebla City, 72424

Mexico

Local Institution - 0097

Amsterdam, North Holland 1081 HV

Netherlands

Local Institution - 0099

Arnhem, 6815 AD

Netherlands

Local Institution - 0098

Groningen, 9713 GZ

Netherlands

Local Institution - 0193

Konin, Greater Poland Voivodeship 62-500

Poland

Local Institution - 0241

Poznan, Greater Poland Voivodeship 60-192

Poland

Local Institution - 0192

Prabuty, Pomeranian Voivodeship 82-550

Poland

Local Institution - 0195

Bydgoszcz, 85796

Poland

Local Institution - 0189

Lodz, Łódź Voivodeship 93-338

Poland

Local Institution - 0133

Bucharest, Bucharest 013812

Romania

Local Institution - 0135

Bucharest, Bucharest 022328

Romania

Local Institution - 0137

Florești, Cluj 407280

Romania

Local Institution - 0140

Craiova, Dolj 200542

Romania

Local Institution - 0141

Cluj-Napoca, 400015

Romania

S.C. Centrul de Oncologie Euroclinic S.R.L.

Iași, 700106

Romania

Institutul Regional de Oncologie

Iași, 700483

Romania

Local Institution - 0305

Cheongju-si, Chungcheongbuk-do [Chungbuk] 28644

South Korea

Local Institution - 0286

Seongnam, Kyǒnggi-do 13620

South Korea

Local Institution - 0304

Suwon, Kyǒnggi-do 16499

South Korea

Local Institution - 0285

Seoul, Seoul-teukbyeolsi [Seoul] 03722

South Korea

Local Institution - 0293

Seoul, Seoul-teukbyeolsi [Seoul] 05505

South Korea

Local Institution - 0309

Daegu, Taegu-Kwangyǒkshi 42601

South Korea

Local Institution - 0300

Santiago de Compostela, A Coruña [La Coruña] 15706

Spain

Local Institution - 0294

Barcelona, Catalunya [Cataluña] 08036

Spain

Local Institution - 0302

Barcelona, Catalunya [Cataluña] 08041

Spain

Local Institution - 0301

Jaén, Jaén 23007

Spain

Local Institution - 0298

Madrid, Madrid, Comunidad de 28034

Spain

Local Institution - 0296

Madrid, Madrid, Comunidad de 28041

Spain

Local Institution - 0297

Majadahonda, Madrid, Comunidad de 28222

Spain

Local Institution - 0303

Valencia, Valenciana, Comunitat 46014

Spain

Local Institution - 0299

Seville, 41009

Spain

Local Institution - 0295

Seville, 41013

Spain

Local Institution - 0248

Chur, 7000

Switzerland

Local Institution - 0249

Winterthur, 8401

Switzerland

Local Institution - 0247

Zurich, 8091

Switzerland

Local Institution - 0158

Çiğli, İzmir 35620

Turkey (Türkiye)

Local Institution - 0154

Adana, 01370

Turkey (Türkiye)

Local Institution - 0157

Ankara, 06010

Turkey (Türkiye)

Local Institution - 0177

Ankara, 06280

Turkey (Türkiye)

Local Institution - 0153

Istanbul, 34732

Turkey (Türkiye)

Local Institution - 0183

Central Middlesbrough, Middlesbrough TS4 3BW

United Kingdom

Local Institution - 0159

Aberdeen, AB9 2ZB

United Kingdom

Local Institution - 0101

Manchester, M20 4BX

United Kingdom

Local Institution - 0226

Metropolitan Borough of Wirral, CH63 4JY

United Kingdom